Vaccine Therapy in Treating Patients With Stage I or Stage II Pancreatic Cancer
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Purpose
RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune response to and kill tumor cells. Combining vaccine therapy with surgery may be an effective treatment for pancreatic cancer.
PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients with stage I or stage II pancreatic cancer that has been surgically removed.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer |
Biological: vitespen |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase I Pilot Trial of Immunotherapy With Autologous Tumor-Derived gp96 Heat Shock Protein - Peptide Complex (HSPPC-96) in Patients With Resected Pancreatic Adenocarcinoma |
| Estimated Enrollment: | 16 |
| Study Start Date: | March 1997 |
| Primary Completion Date: | July 2002 (Final data collection date for primary outcome measure) |
OBJECTIVES: I. Study the safety of autologous tumor derived gp96 heat shock protein peptide complex (HSPPC-96) in patients with resected pancreatic adenocarcinoma. II. Examine the immune response to HSPPC-96 in this group of patients.
OUTLINE: This is a dose escalation study. Six weeks after surgery patients are given autologous tumor derived gp96 heat shock protein peptide complex (HSPPC-96) subcutaneously once a week for 4 weeks. Five patients are initially enrolled at each of two dose levels. An additional three patients may be enrolled at each dose level to determine the optimal dose of HSPPC-96. Patients are followed at weeks 1, 4, and 12 after treatment.
PROJECTED ACCRUAL: A maximum of 16 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven, resected, stage I or II pancreatic adenocarcinoma
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: WBC at least 3000/mm3 Lymphocyte count at least 700/mm3 Platelet count at least 100,000/mm3 Hepatic: Not specified Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No clinically significant heart disease Other: No other serious illness No active infections requiring antibiotics within past 2 weeks Not pregnant or nursing Fertile patients must use effective birth control No known immunodeficiency No active bleeding
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy Chemotherapy: No prior chemotherapy Endocrine therapy: No concurrent corticosteroids Radiotherapy: No prior radiation therapy Surgery: Must undergo Whipple procedure or distal pancreatectomy at Memorial Hospital Must not have undergone splenectomy Other: No investigational treatment within 2 months of surgery No immunosuppressive therapies
Contacts and Locations| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Study Chair: | Jonathan Lewis, MD, PhD, FACS | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00003025 History of Changes |
| Other Study ID Numbers: | CDR0000065613, MSKCC-97034, ANTIGENICS-C-100-01, NCI-G97-1271 |
| Study First Received: | November 1, 1999 |
| Last Updated: | December 2, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage I pancreatic cancer stage II pancreatic cancer adenocarcinoma of the pancreas |
Additional relevant MeSH terms:
|
Adenocarcinoma Pancreatic Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Digestive System Neoplasms Neoplasms by Site Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013